A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study (STAR)

AstraZeneca

Status and phase: Terminated; Phase 4

Conditions: Acute Bipolar Mania

Treatments: Drug: lithium; Drug: Quetiapine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254721

D1443L00086

Details and patient eligibility

About

The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.

Full description

A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study.

Enrollment: 131 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
• Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
• YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
• Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive

Exclusion criteria

• Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
• Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

1

Experimental group

Description:

Seroquel XR tablet

Treatment:

Drug: Quetiapine fumarate

2

Active Comparator group

Description:

Seroquel XR + lithium

Treatment:

Drug: lithium

Drug: Quetiapine fumarate